Aortic Stenosis, SevereNCT05168826
China S3 PMS: SAPIEN 3 China Post Market Registry Study
An observational study of Aortic Stenosis, Severe, run by Edwards Lifesciences at 14 sites in China.
Trial summary
The objective of this study is to evaluate the long term safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve system in real world setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Stenosis, Severe
- What is being tested?
- SAPIEN 3 Transcatheter Heart Valve
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 14 sitesChina
- Study dates
- 24 Jan 2022to Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who will undergo TAVI with the Edwards SAPIEN 3 System.
Who may be able to join
- Patient with symptomatic, severe, calcified aortic stenosis who is appropriate for the treatment with transcatheter aortic valve replacement as determined by a heart team and will undergo TAVI with the Edwards SAPIEN 3 System as part of standard-of-care treatment
- All surgical risks as determined by the site Heart Team
- The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Who cannot join
- Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship
- Considered to be part of a vulnerable population
- Pre-existing mechanical or bioprosthetic aortic valve
- Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
- Cannot tolerate an anticoagulation/antiplatelet regimen
- Evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis
- Tortuous or calcified vessels that would prevent safe entry of the dilators and sheath
- Participating in a drug or device study that has not reached its primary endpoint
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Peking University Third Hospital
Beijing, Beijing Municipality, 100000
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000
First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Shanghai General Hospital
Shanghai, Shangahi, 200000
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200000
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200000
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830000
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430022
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, 710000
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, 361004
Henan Provincial Chest Hospital
Zhengzhou, Henan, 450000
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
About this study
Official title: SAPIEN 3 China Post Market Registry Study
The objective of this study is to evaluate the long term safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve system in real world setting.
Read the detailed description
This is an observational, single-arm, multicentre, post-market study.
- Conditions
- Aortic Stenosis, Severe
- Being tested
- SAPIEN 3 Transcatheter Heart Valve
- Keywords
- Transcatheter aortic valve implantation (TAVI), Transcatheter aortic valve replacement (TAVR), SAPIEN 3, Heart disease, Cardiovascular disease
- Medical subject headings
- Aortic Valve Stenosis, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAPIEN 3 Transcatheter Heart ValveDevice
Implantation of the SAPIEN 3 valve
| Study group | Role | What they receive |
|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI) | Not described Receives: Device: SAPIEN 3 Transcatheter Heart Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
The number of patients that died
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start24 Jan 2022
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis, SevereStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168826
- Sponsor's protocol ID
- 2021-06
- Status last verified
- Aug 2026
- First submitted
- 10 Dec 2021
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAPIEN 3 China Post Market Registry Study
- ClinicalTrials.gov ID
- NCT05168826
- Acronym / sponsor ID
- 2021-06
- Conditions
- Aortic Stenosis, Severe
- Keywords
- Transcatheter aortic valve implantation (TAVI), Transcatheter aortic valve replacement (TAVR), SAPIEN 3, Heart disease, Cardiovascular disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the long term safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve system in real world setting.
Detailed description
This is an observational, single-arm, multicentre, post-market study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcatheter Aortic Valve Implantation (TAVI) | – | Device: SAPIEN 3 Transcatheter Heart Valve |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who will undergo TAVI with the Edwards SAPIEN 3 System.
Key inclusion criteria (3 listed)
- Patient with symptomatic, severe, calcified aortic stenosis who is appropriate for the treatment with transcatheter aortic valve replacement as determined by a heart team and will undergo TAVI with the Edwards SAPIEN 3 System as part of standard-of-care treatment
- All surgical risks as determined by the site Heart Team
- The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Key exclusion criteria (8 listed)
- Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship
- Considered to be part of a vulnerable population
- Pre-existing mechanical or bioprosthetic aortic valve
- Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
- Cannot tolerate an anticoagulation/antiplatelet regimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAPIEN 3 Transcatheter Heart ValveImplantation of the SAPIEN 3 valve | Device | Transcatheter Aortic Valve Implantation (TAVI) |
Primary outcome
All-cause mortality
Time frame: 10 years
The number of patients that died
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Stenosis, Severe, run by Edwards Lifesciences at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.